Opinion 8.045 - Direct-to-Consumer Diagnostic Imaging Tests

Diagnostic imaging services that have not been scientifically validated for screening purposes are being offered without prior referral by a personal physician. Examples include total body scanning, electron beam computed tomography (CT) for determining coronary artery calcification, spiral CT for lung cancer screening, and CT colonography for colon cancer screening. Physicians and relevant specialty societies should advocate for the conduct of appropriate trials aimed at determining the predictive power of the tests, and their sensitivity and specificity for target abnormalities. When adequate data regarding a screening diagnostic imaging service become available, the profession has a responsibility to develop suitable guidelines, as has been done for mammography.

The following ethical guidelines apply to physicians providing screening imaging services that have not been scientifically validated, without referral from another physician:

(1) Performance of a diagnostic imaging test at the request of an individual is justifiable only if, in the judgment of the physician, the potential benefits of the service outweigh the risks.

(2) Once a physician agrees to perform the test, a patient-physician relationship is established with all the obligations such a relationship entails. (See Opinion 10.01, "Fundamental Elements of the Patient-Physician Relationship" and Opinion 10.015, "The Patient-Physician Relationship.")

In the absence of a referring physician who orders the test, the testing physician assumes responsibility for relevant clinical evaluation, as well as pre-test and post-test counseling concerning the test, its results, and indicated follow-up. Post-test counseling may also be accomplished through referral to an appropriate physician who accepts the patient.

In obtaining the patient’s informed consent (see Opinion 8.08, "Informed Consent"), the testing physician should discuss, in a manner the patient can understand, the usual elements of informed consent as well as:

(a) the inaccuracies inherent in the proposed test,

(b) the possibility of inconclusive results,

(c) false positives or false negatives, and

(d) circumstances which may require further assessment and additional costs.

(3) Physicians who hold financial interests in imaging facilities must not place those interests above the welfare of their patients, as stated in Opinions 8.03, "Conflicts of Interest: Guidelines" and 8.032, "Conflicts of Interest: Health Facility Ownership by a Physician." Moreover, physicians who advertise diagnostic imaging services should ensure that advertisements are truthful and not misleading or deceptive. (I, II, V, VIII)